FDA.reportPublic FDA data

Acetaminophen

Product NDC
71335-3130
11-digit product format
713353130
Labeler code
71335
Product ID
71335-3130_7db1fd81-3443-4722-9a1b-497eace4d3c4
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-09
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
816b65d7-e53f-44c4-a418-074279d4b2afAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3130-0Acetaminophen24 in 1 BOTTLETABLET, FILM COATED241
71335-3130-1Acetaminophen20 in 1 BOTTLETABLET, FILM COATED201
71335-3130-2Acetaminophen100 in 1 BOTTLETABLET, FILM COATED1001
71335-3130-3Acetaminophen30 in 1 BOTTLETABLET, FILM COATED301
71335-3130-4Acetaminophen2 in 1 BOTTLETABLET, FILM COATED21
71335-3130-5Acetaminophen6 in 1 BOTTLETABLET, FILM COATED61
71335-3130-6Acetaminophen10 in 1 BOTTLETABLET, FILM COATED101
71335-3130-7Acetaminophen60 in 1 BOTTLETABLET, FILM COATED601
71335-3130-8Acetaminophen90 in 1 BOTTLETABLET, FILM COATED901
71335-3130-9Acetaminophen40 in 1 BOTTLETABLET, FILM COATED401

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN816b65d7-e53f-44c4-a418-074279d4b2af1
313782acetaminophen 325 MG Oral TabletSCD816b65d7-e53f-44c4-a418-074279d4b2af1
313782APAP 325 MG Oral TabletSY816b65d7-e53f-44c4-a418-074279d4b2af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3130-07133531300024 TABLET, FILM COATED in 1 BOTTLE (71335-3130-0) 2026-05-08NoNoCurrent
71335-3130-17133531300120 TABLET, FILM COATED in 1 BOTTLE (71335-3130-1) 2026-05-08NoNoCurrent
71335-3130-271335313002100 TABLET, FILM COATED in 1 BOTTLE (71335-3130-2) 2026-05-08NoNoCurrent
71335-3130-37133531300330 TABLET, FILM COATED in 1 BOTTLE (71335-3130-3) 2026-05-08NoNoCurrent
71335-3130-4713353130042 TABLET, FILM COATED in 1 BOTTLE (71335-3130-4) 2026-05-08NoNoCurrent
71335-3130-5713353130056 TABLET, FILM COATED in 1 BOTTLE (71335-3130-5) 2026-05-08NoNoCurrent
71335-3130-67133531300610 TABLET, FILM COATED in 1 BOTTLE (71335-3130-6) 2026-05-08NoNoCurrent
71335-3130-77133531300760 TABLET, FILM COATED in 1 BOTTLE (71335-3130-7) 2026-05-08NoNoCurrent
71335-3130-87133531300890 TABLET, FILM COATED in 1 BOTTLE (71335-3130-8) 2026-05-08NoNoCurrent
71335-3130-97133531300940 TABLET, FILM COATED in 1 BOTTLE (71335-3130-9) 2026-05-08NoNoCurrent